Endoscopic biliary drainage in unresectable biliary obstruction: the role of endoscopic ultrasound-guidance in a cohort study.

BACKGROUND AND STUDY AIMS: the use of endoscopic ultrasound-guided biliary drainage (EUS-BD) has increased in cases of failed endoscopic retrograde cholangiopancreatography (ERCP) and there are some concerns. The main aim of the study was to determine the role of EUS-BD in a palliative case cohort. The secondary aim was to compare the efficacy, safety and survival of EUS-BD and ERCP procedures. PATIENTS AND METHODS: this was an observational study at a single tertiary institution, with a consecutive inclusion from January 2015 to December 2016. The inclusion criteria were unresectable tumors of the biliopancreatic region with an indication of BD. Statistical comparison analysis was performed between the ERCP and EUS-BD groups. The incidence between groups was compared using the Chi-square and Fisher exact tests. The log rank test was used to compare the risk of death. RESULTS: fifty-two cases with an indication of palliative BD were included in the study. Transpapillary drainage via ERCP was possible in 44 procedures and EUS-BD was required in eight cases; 15.4% of the cohort and seven using lumen apposing metal stent (LAMS). The technical and clinical success of global endoscopic BD was 100% and 88.5% (ERCP: 84.6% and 78.9%; EUS-BD: 100% and 62.5%, respectively). Pancreatitis was the most frequent adverse event (AE) in the ERCP group (9.62%) and bleeding in the EUS-BD (25%). There were fatal AEs in ERCP (1.9%) and EUS-BD (25%) cases. Patient survival was higher with ERCP transpapillary stents compared to EUS-guided stents, which was statistically significant (p = 0.007). CONCLUSIONS: the requirement of EUS-BD in palliative biliopancreatic pathology is not marginal. EUS-BD is associated with a lower survival rate and a higher rate of fatal AE, which argues against its use as a first choice procedure.

The safety of nurse-administered procedural sedation compared to anesthesia care in a historical cohort of advanced endoscopy patients.

BACKGROUND: In April 2010, in response to a change in Centers for Medicare and Medicaid Services regulation placing deep sedation under hospital anesthesia services, our institution began providing anesthesia care for all advanced endoscopic procedures. Because it remains unknown whether anesthesia care reduces sedation-related complications or improves quality of care versus nurse-administered sedation for endoscopic retrograde cholangiopancreatography and endoscopic ultrasound patients, we retrospectively compared complications in a 5-year historical cohort before and after the policy change. METHODS: We reviewed a historical cohort of 9598 consecutive endoscopic retrograde cholangiopancreatography and endoscopic ultrasound examinations for adult patients at a single institution during a 5-year period (October 2007-October 2012). We compared procedures performed before and after the policy change for the incidence of sedation, endoscopic, and total complications, and for major morbidity and mortality. RESULTS: The incidence of reported sedation-related complications was 0.38% (17 of 4514) before the policy change and 0.08% (4 of 5084) after the policy change, which was statistically significant (P = 0.002, diff = 0.3, 95% confidence interval, 0.11%-0.53%). Endoscopic complications were not significantly different before versus after: 0.66% vs 0.87% (P = 0.293, diff = 0.2, 95% confidence interval, -0.16% to 0.56%). Total complications (1.11% vs 1.00%, P = 0.618) and major morbidity and mortality (0.27% vs 0.33%, P = 0.581) did not differ between the 2 time periods. CONCLUSIONS: Anesthesia care for advanced endoscopy in a high-risk population significantly reduced sedation complications compared with nurse-administered sedation. Endoscopic complications were unchanged. The sedation risk reduction did not reduce major morbidity, mortality, or total complications.

A novel technique for endoscopic ultrasound-guided biliary drainage.

AIM: To describe a successful endoscopic ultrasound (EUS)-guided biliary drainage technique with high success and low complication rates. METHODS: The recorded data of consecutive patients who presented to Siriraj Gastrointestinal Endoscopy Center, Siriraj Hospital in Bangkok, Thailand for treatment of malignant obstructive jaundice but failed endoscopic retrograde cholangiopancreatography and underwent subsequent EUS-guided biliary drainage were retrospectively reviewed. The patients' baseline characteristics, clinical manifestations, procedure details, and post-procedure follow-up data were recorded and analyzed. Clinical outcomes were assessed by physical exam and standard laboratory tests. Technical success of the procedure was defined as completion of the stent insertion. Clinical success was defined as improvement of the patient's overall clinical manifestations, in terms of general well-being evidenced by physical examination, restoration of normal appetite, and adequate biliary drainage. Overall median survival time was calculated as the time from the procedure until the time of death, and survival analysis was performed by the Kaplan-Meier method. The Student's t-test and the χ(2) test were used to assess the significance of inter-group differences. RESULTS: A total of 21 cases were enrolled, a single endoscopist performed all the procedures. The mean age was 62.8 years (range: 46-84 years). The sex distribution was almost equal, including 11 women and 10 men. Patients with failed papillary cannulation (33.3%), duodenal obstruction (42.9%), failed selective cannulation (19.0%), and surgical altered anatomy (4.8%) were considered candidates for EUS-guided biliary drainage. Six patients underwent EUS-guided choledochoduodenostomy and 15 underwent EUS-guided hepaticogastrostomy. The technique using non-cauterization and no balloon dilation was performed for all cases, employing the in-house manufactured tapered tip Teflon catheter to achieve the dilation. The technical success and clinical success rates of this technique were 95.2% and 90.5%, respectively. Complications included bile leakage and pneumoperitoneum, occurred at a rate of 9.5%. None of the patients died from the procedure. One patient presented with a biloma, a major complication that was successfully treated by another endoscopic procedure. CONCLUSION: We present a highly effective EUS-guided biliary drainage technique that does not require cauterization or balloon dilation.

[Complications of endoscopic ultrasound and endoscopic ultrasound-guided interventions - results of a survey among German centers]. / Komplikationen der Endosonografie und endosonografischer Interventionen - Ergebnisse einer Umfrage an deutschen Zentren.

BACKGROUND: Endoscopic ultrasonography is a widely used technique in Germany and not restricted to highly specialised centres. Complementary to the traditional radial scanners, longitudinally scanning echo endoscopes have gained considerable acceptation. Multicentre data on the complications of endoscopic ultrasound and endoscopic ultrasound-guided interventions at German centres do not exist. METHOD: From 2004 to 2006 all German centres performing endoscopic ultrasonography were surveyed and asked to report on their complications. RESULTS: From 1991 to 2006 100 604 endosonographic procedures had been performed in 67 centres (85,084 diagnostic endosonographies without any intervention, 13,223 endoscopic ultrasound-guided finde-needle aspiration biopsies, 2297 endoscopic ultrasound-guided therapeutic interventions). 38 centres reported on 104 complications, of which 88 were considered to be severe (overall complication rate 0.1 %). Complications of diagnostic endoscopic ultrasound occurred at a rate of 0.034 %, almost all of them were duodenal and oesophageal perforations. There had been complications in 0.29 % of all endoscopic ultrasound-guided fine-needle aspiration biopsies and subsequent to 1.61 % of all endoscopic ultrasound-guided therapeutic interventions. The overall mortality of non-interventional and interventional endosonographic procedures was 0.01 %. CONCLUSIONS: Under the specific circumstances in Germany, endoscopic ultrasound, both conventional and interventional, was confirmed to be a safe diagnostic and therapeutic technique. In future, the prospective assessment of complications should become an essential part of quality management of endoscopic ultrasound.

Early morbidity of endoscopic ultrasound: 13 years' experience at a referral center.

BACKGROUND AND STUDY AIM: Endoscopic ultrasonography (EUS) now has an important place in the diagnosis of gastroenteropancreatic diseases. However, prospective data on the morbidity and mortality related to its use are sparse and often retrospective. We attempted to assess the acute and immediate complications of both diagnostic and interventional EUS. PATIENTS AND METHODS: At our university-affiliated tertiary care referral center, immediate (occurring during the procedure) and acute (occurring within 24 hours) complications of EUS were prospectively investigated. Over a first period, spanning 10 years, complications of diagnostic EUS involving 3207 consecutive patients were assessed. During the second period of 3 years, complications observed after EUS-guided fine-needle aspiration (FNA) biopsy were evaluated from 224 procedures. EUS was mostly done with the patient under sedation with intravenous propofol and spontaneous ventilation, and complications were evaluated by both the operator and the anesthesiologist. RESULTS: There were no deaths, and no surgery was required over the two periods of assessment. Three mild complications occurred among patients who underwent standard diagnostic EUS: two immediate complications were related to anesthesia and one to the procedure. There were five complications associated with interventional EUS; all were related to the procedure (acute pancreatitis, duodenal perforation, upper digestive bleeding, cyst, and mediastinal infection), with a mean delay of occurrence of 30 hours, and mean duration of hospitalization of 7 days. CONCLUSION: In our experience, which is the longest reported in Europe, the morbidity rates of diagnostic EUS and EUS-guided FNA biopsy were 0.093% and 2.2%, respectively, with no mortality.

Long-term results in patients with T2-3 N0 distal rectal cancer undergoing radiotherapy before transanal endoscopic microsurgery.

BACKGROUND: Local excision after radiotherapy for node-negative low rectal cancer may be an alternative to radical excision. This study evaluated the results of local excision in patients with small (less than 3 cm in diameter) T2 and T3 distal rectal tumours following neoadjuvant therapy. METHODS: One hundred patients with rectal cancer (54 uT2 and 46 uT3 uN0 tumours) were enrolled. All patients underwent preoperative radiotherapy followed by local excision by means of transanal endoscopic microsurgery. RESULTS: Definitive histological examination revealed nine pT1, 54 pT2 and 19 pT3 tumours. A complete response (R0) or microscopic residual tumour (R1mic) was found in three and 15 patients respectively. Minor complications occurred in 11 patients and major complications in two. At a median follow-up of 55 (range 7-120) months, the local failure rate was 5 per cent and metastatic disease was found in two patients. The cancer-specific survival rate at 90 months' follow-up was 89 per cent, and the overall survival rate 72 per cent. Salvage abdominoperineal resection was performed in three patients, two of whom were disease free at 15 and 19 months. CONCLUSION: Treatment of small uT2 and uT3 uN0 rectal cancers with preoperative high-dose radiotherapy followed by transanal endoscopic microsurgery is an acceptable alternative to conventional radical resection.

Prospective evaluation of patient tolerability, satisfaction with patient information, and complications in endoscopic ultrasonography.

BACKGROUND AND STUDY AIMS: Prospective data are lacking on the safety of endoscopic ultrasonography (EUS) and on patient satisfaction with the procedure. We prospectively recorded complications related to EUS in order to establish morbidity and mortality. In addition the levels of patient satisfaction were evaluated, with regard to the tolerability of the procedure (pain, discomfort, and anxiety levels) and the provision of information. PATIENTS AND METHODS: 3324 consecutive patients who underwent EUS were studied with regard to complications. During the study period 300 patients were interviewed and followed up in detail as part of the evaluation of patient satisfaction. RESULTS: Ten patients (0.3 %) suffered from a complication related to the EUS procedure, and two patients died (0.06 %). There were no significant differences between the complication rates for EUS-guided fine-needle aspiration (EUS-FNA) and for EUS, but both fatal cases related to EUS-FNA/EUS-guided intervention. Nine of the ten patients with complications (90 %) had a diagnosis of malignancy, and esophageal perforation accounted for half of all complications. Although the majority of patients with nonlethal complications were managed well on conservative regimens, only one case, of self-limiting acute pancreatitis, could be classified as a mild complication. With regard to patient tolerability, only minor incidents occurred during the EUS procedure (tracheal suction 5 %, vomiting 0.3 %, aspiration 0.3 %) and no intervention was necessary. During the procedure, 80 % of the patients had no or only slight pain and more than 95 % experienced only slight or no anxiety, whereas more than half of the patients experienced moderate to severe discomfort. More than 90 % of the patients were satisfied or very satisfied with the information provided to them before and after the EUS, and the same number of patients were ready without hesitation to undergo an additional EUS examination if necessary. CONCLUSIONS: EUS, EUS-FNA and EUS-guided intervention are safe techniques, but severe and lethal complications do occur. The EUS procedures can be performed with a high level of patient satisfaction and with low levels of pain, discomfort and anxiety.